Premature EjaculationNCT07300774
Vagus Nerve Stimulation in Premature Ejaculation
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Premature Ejaculation, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
Trial summary
Introduction: Premature ejaculation (PE), one of the most common sexual dysfunctions in men, negatively affects sexual function and quality of life. Transcutaneous auricular vagal nerve stimulation (taVNS) provides autonomic regulation non-invasively by balancing the sympathetic and parasympathetic systems. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Ejaculation
- What is being tested?
- Transcutaneous Auricular Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2025to 3 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Having a diagnosis of premature ejaculation according to the International Society for Sexual Medicine (ISSM),
- Having the same, non-pregnant, sexually active partner for at least 6 months,
- Being in a stable, heterosexual relationship,
- Suffering from PE and seeking medical treatment.
Who cannot join
- Having acquired PE,
- History of vagotomy,
- Having diabetes, hypertension, cardiovascular disease,
- Abnormal neurological examination findings,
- Use of drugs that impair heart rate variability (agents, a-receptor agonists or antagonists, tricyclic or serotonergic antidepressants, antihypertensive drugs)
- History of pelvic surgery,
Show all 11Show fewer
- Tobacco or alcohol use,
- Any organic cause of PE (as assessed by prostatic secretion analysis, thyroid-stimulating hormone);
- Having a psychiatric disorder,
- Having skin irritation/lesion at the application site,
- International Index of Erectile Function score below 26
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bahcesehir University
Istanbul, Beşiktaş, 34000
About this study
Official title: Transcutaneous Vagus Nerve Stimulation in Premature Ejaculation
Introduction: Premature ejaculation (PE), one of the most common sexual dysfunctions in men, negatively affects sexual function and quality of life. Transcutaneous auricular vagal nerve stimulation (taVNS) provides autonomic regulation non-invasively by balancing the sympathetic and parasympathetic systems.
Objective: To investigate the effectiveness of taVNS on autonomic and sexual function in men with PE and to compare the effectiveness of different taVNS application methods.
Materials and Methods: This prospective, randomized, sham-controlled, single-blind (evaluator) study will be conducted on 102 men with PE. Physical, sociodemographic, and clinical characteristics will be evaluated. Heart rate variability will be assessed using the Polar H10 device, premature ejaculation status using the Premature Ejaculation Assessment Questionnaire, and sexual function using the International Index of Erectile Function. Participants will be randomized into two groups (intra-auricular taVNS and sham-taVNS). taVNS treatment will be administered to each group three days per week, with 20-minute sessions, for 12 weeks. For in-ear taVNS, bilateral ear sets with a 36-square-millimeter surface area will be used to stimulate the tragus and concha will be used to stimulate the tragus and concha for intra-auricular taVNS, while adhesive electrode pads with a similar surface area of 36 square millimeters (3 mm × 12 mm) will be used for retroauricular taVNS. The taVNS protocol includes bilateral auricular stimulation for 20 minutes, a stimulation frequency of 25 hertz (Hz), a pulse width of 250 μs, suprathreshold current (0.13-50 mA), and a biphasic mode. Sham group will also have the same specially designed electrodes placed inside the ear. The device will be turned on but set to 0 mA amplitude, so no electrical stimulation will be delivered.
Read the detailed description
Premature ejaculation (PE) is one of the most common sexual dysfunctions in men, profoundly affecting the quality of life of both the patient and their partner. Many of the proposed definitions for PE are not based on scientific data and lack diagnostic criteria. The International Society for Sexual Medicine (ISSM) defines PE (lifelong and acquired) as characterized by the following criteria: Ejaculation that occurs almost always or always before or within 1 minute of vaginal penetration (lifelong PE) or a clinically significant decrease in ejaculation latency time, typically to 3 minutes or less (acquired PE); Inability to delay ejaculation in almost all or all vaginal penetrations (lifelong and acquired PE); Negative personal consequences such as distress, anxiety, disappointment, and/or avoidance of sexual intimacy (lifelong and acquired PE). Epidemiological studies based on patient-reported outcome measures have found the prevalence of PE complaints in the male population to be as high as 20-30%. A review of the literature reveals that approaches such as behavioral therapy, exercise programs, neuromuscular electrical stimulation, and yoga are used in the treatment of premature ejaculation, in addition to pharmacological treatment. However, no study has been found that examines the effectiveness of transcutaneous auricular vagal nerve stimulation on autonomic function and PE in men with PE. Therefore, this study was designed to examine the effects of taVNS on autonomic function and PE in men with PE. Participants will be randomly assigned to two groups (intra-auricular taVNS and intra-auricular sham-taVNS). The taVNS will be administered to each group three days per week, with 20-minute session durations, for 12 weeks. The taVNS protocol includes bilateral auricular stimulation for 20 minutes, a stimulation frequency of 25 hertz (Hz), a pulse width of 250 μs, suprathreshold current (0.13-50 mA), and a biphasic mode. For intra-auricular taVNS, bilateral ear sets with a 36-square-millimeter surface area to stimulate the tragus and concha will be used for intra-auricular taVNS. Sham group will also have the same specially designed electrodes placed intra-auricularly. The device will be turned on but set to 0 mA amplitude, so no electrical stimulation will occur. Heart rate variability, Premature Ejaculation Assessment Questionnaire, International Index of Erectile Function will be assessed before and after treatment.
- Conditions
- Premature Ejaculation
- Being tested
- Transcutaneous Auricular Vagus Nerve Stimulation
- Keywords
- Vagus nerve stimulation, Heart Rate Variability, Premature Ejaculation
- Medical subject headings
- Premature Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Auricular Vagus Nerve StimulationDevice
Non-invasive electrical stimulation of the vagus nerve via the tragus and conchae
| Study group | Role | What they receive |
|---|---|---|
| Stimulation Group | Active comparator | Transcutaneous auricular vagus nerve stimulation Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
| Sham Stimulation Group | Placebo comparator | Sham Stimulation Receives: Device: Transcutaneous Auricular Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Variability
Heart rate variability will be measured for 5 minutes over the chest using the Polar H10 device.
Measured: Baseline and at the end of the 12th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2025
- Study start1 Dec 2025
- Primary completion30 Apr 2026
- Study completion3 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Premature EjaculationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A comparison between transcutaneous auricular vagus nerve stimulation and sham stimulation will be performed.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bahçeşehir University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alper Percin, Bahçeşehir University
- Investigators
- Ramazan Cihad Yılmaz, Ph.D., Study director, Igdir University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07300774
- Sponsor's protocol ID
- AVU00011
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2025
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A decision on this matter will be made later.
Publications
Ventus D, Jern P. Lifestyle Factors and Premature Ejaculation: Are Physical Exercise, Alcohol Consumption, and Body Mass Index Associated With Premature Ejaculation and Comorbid Erectile Problems? J Sex Med. 2016 Oct;13(10):1482-7. doi: 10.1016/j.jsxm.2016.08.007. Epub 2016 Aug 31.
PubMed 27590186Jiang M, Yan G, Deng H, Liang H, Lin Y, Zhang X. The efficacy of regular penis-root masturbation, versus Kegel exercise in the treatment of primary premature ejaculation: A quasi-randomised controlled trial. Andrologia. 2020 Feb;52(1):e13473. doi: 10.1111/and.13473. Epub 2019 Nov 20.
PubMed 31746051La Pera G. Awareness and timing of pelvic floor muscle contraction, pelvic exercises and rehabilitation of pelvic floor in lifelong premature ejaculation: 5 years experience. Arch Ital Urol Androl. 2014 Jun 30;86(2):123-5. doi: 10.4081/aiua.2014.2.123.
PubMed 25017593
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Vagus Nerve Stimulation in Premature Ejaculation
- ClinicalTrials.gov ID
- NCT07300774
- Acronym / sponsor ID
- AVU00011
- Conditions
- Premature Ejaculation
- Keywords
- Vagus nerve stimulation, Heart Rate Variability, Premature Ejaculation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Bahçeşehir UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 3 May 2026 (actual)
- First posted
- 24 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Introduction: Premature ejaculation (PE), one of the most common sexual dysfunctions in men, negatively affects sexual function and quality of life. Transcutaneous auricular vagal nerve stimulation (taVNS) provides autonomic regulation non-invasively by balancing the sympathetic and parasympathetic systems.
Objective: To investigate the effectiveness of taVNS on autonomic and sexual function in men with PE and to compare the effectiveness of different taVNS application methods.
Materials and Methods: This prospective, randomized, sham-controlled, single-blind (evaluator) study will be conducted on 102 men with PE. Physical, sociodemographic, and clinical characteristics will be evaluated. Heart rate variability will be assessed using the Polar H10 device, premature ejaculation status using the Premature Ejaculation Assessment Questionnaire, and sexual function using the International Index of Erectile Function. Participants will be randomized into two groups (intra-auricular taVNS and sham-taVNS). taVNS treatment will be administered to each group three days per week, with 20-minute sessions, for 12 weeks. For in-ear taVNS, bilateral ear sets with a 36-square-millimeter surface area will be used to stimulate the tragus and concha will be used to stimulate the tragus and concha for intra-auricular taVNS, while adhesive electrode pads with a similar surface area of 36 square millimeters (3 mm × 12 mm) will be used for retroauricular taVNS. The taVNS protocol includes bilateral auricular stimulation for 20 minutes, a stimulation frequency of 25 hertz (Hz), a pulse width of 250 μs, suprathreshold current (0.13-50 mA), and a biphasic mode. Sham group will also have the same specially designed electrodes placed inside the ear. The device will be turned on but set to 0 mA amplitude, so no electrical stimulation will be delivered.
Detailed description
Premature ejaculation (PE) is one of the most common sexual dysfunctions in men, profoundly affecting the quality of life of both the patient and their partner. Many of the proposed definitions for PE are not based on scientific data and lack diagnostic criteria. The International Society for Sexual Medicine (ISSM) defines PE (lifelong and acquired) as characterized by the following criteria: Ejaculation that occurs almost always or always before or within 1 minute of vaginal penetration (lifelong PE) or a clinically significant decrease in ejaculation latency time, typically to 3 minutes or less (acquired PE); Inability to delay ejaculation in almost all or all vaginal penetrations (lifelong and acquired PE); Negative personal consequences such as distress, anxiety, disappointment, and/or avoidance of sexual intimacy (lifelong and acquired PE). Epidemiological studies based on patient-reported outcome measures have found the prevalence of PE complaints in the male population to be as high as 20-30%. A review of the literature reveals that approaches such as behavioral therapy, exercise programs, neuromuscular electrical stimulation, and yoga are used in the treatment of premature ejaculation, in addition to pharmacological treatment. However, no study has been found that examines the effectiveness of transcutaneous auricular vagal nerve stimulation on autonomic function and PE in men with PE. Therefore, this study was designed to examine the effects of taVNS on autonomic function and PE in men with PE. Participants will be randomly assigned to two groups (intra-auricular taVNS and intra-auricular sham-taVNS). The taVNS will be administered to each group three days per week, with 20-minute session durations, for 12 weeks. The taVNS protocol includes bilateral auricular stimulation for 20 minutes, a stimulation frequency of 25 hertz (Hz), a pulse width of 250 μs, suprathreshold current (0.13-50 mA), and a biphasic mode. For intra-auricular taVNS, bilateral ear sets with a 36-square-millimeter surface area to stimulate the tragus and concha will be used for intra-auricular taVNS. Sham group will also have the same specially designed electrodes placed intra-auricularly. The device will be turned on but set to 0 mA amplitude, so no electrical stimulation will occur. Heart rate variability, Premature Ejaculation Assessment Questionnaire, International Index of Erectile Function will be assessed before and after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A comparison between transcutaneous auricular vagus nerve stimulation and sham stimulation will be performed.
| Arm | Type | Receives |
|---|---|---|
| Stimulation Group | Active comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationTranscutaneous auricular vagus nerve stimulation |
| Sham Stimulation Group | Placebo comparator | Device: Transcutaneous Auricular Vagus Nerve StimulationSham Stimulation |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Having a diagnosis of premature ejaculation according to the International Society for Sexual Medicine (ISSM),
- Having the same, non-pregnant, sexually active partner for at least 6 months,
- Being in a stable, heterosexual relationship,
- Suffering from PE and seeking medical treatment.
Key exclusion criteria (11 listed)
- Having acquired PE,
- History of vagotomy,
- Having diabetes, hypertension, cardiovascular disease,
- Abnormal neurological examination findings,
- Use of drugs that impair heart rate variability (agents, a-receptor agonists or antagonists, tricyclic or serotonergic antidepressants, antihypertensive drugs)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous Auricular Vagus Nerve StimulationNon-invasive electrical stimulation of the vagus nerve via the tragus and conchae | Device | Sham Stimulation Group, Stimulation Group |
Primary outcome
Heart Rate Variability
Time frame: Baseline and at the end of the 12th week
Heart rate variability will be measured for 5 minutes over the chest using the Polar H10 device.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 27590186Ventus D, Jern P. Lifestyle Factors and Premature Ejaculation: Are Physical Exercise, Alcohol Consumption, and Body Mass Index Associated With Premature Ejaculation and Comorbid Erectile Problems? J Sex Med. 2016 Oct;13(10):1482-7. doi: 10.1016/j.jsxm.2016.08.007. Epub 2016 Aug 31.
- Background: PubMed 31746051Jiang M, Yan G, Deng H, Liang H, Lin Y, Zhang X. The efficacy of regular penis-root masturbation, versus Kegel exercise in the treatment of primary premature ejaculation: A quasi-randomised controlled trial. Andrologia. 2020 Feb;52(1):e13473. doi: 10.1111/and.13473. Epub 2019 Nov 20.
- Background: PubMed 25017593La Pera G. Awareness and timing of pelvic floor muscle contraction, pelvic exercises and rehabilitation of pelvic floor in lifelong premature ejaculation: 5 years experience. Arch Ital Urol Androl. 2014 Jun 30;86(2):123-5. doi: 10.4081/aiua.2014.2.123.
- Individual participant dataSharing planned: Undecided. A decision on this matter will be made later.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ramazan Cihad Yılmaz, Ph.D. study director
Igdir University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous Auricular Vagus Nerve Stimulation in people with Premature Ejaculation, run by Bahçeşehir University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Rate Variability (time frame: Baseline and at the end of the 12th week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07300774, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026.